CEL-SCI Corporation (NYSE AMEX: CVM) reports financial
results for the fiscal quarter ended December 31, 2010.
CEL-SCI reported that net income available to shareholders for
the quarter ended December 31, 2010 was a loss of ($6,250,952)
versus a gain of $19,159,517 during the same quarter ended December
31, 2009. Net income per share, basic was a loss of ($0.03) for the
quarter ended December 31, 2010 versus a gain of $0.10 during the
same quarter ended December 31, 2009. The change from a substantial
net income in the quarter ending December 31, 2009 to a loss in the
quarter ending December 31, 2010 was primarily due to a derivative
gain of $23,340,267 million in the 2009 quarter versus a derivative
loss of ($1,946,395) million for the 2010 quarter. The operating
loss for the quarter ended December 31, 2010 was ($4,316,034)
versus an operating loss of ($4,252,849) during the same quarter
ended December 31, 2009. The net cash used during the quarter
ending December 31, 2010 was about $3.6 million.
R&D expenses for the quarter ended December 31, 2010 totaled
$3,264,428 versus R&D expenses of $2,805,127 for the same
quarter in fiscal year 2010. R&D expenses increased due to
higher costs associated with the start up of the Company’s Phase
III clinical trial of its cancer drug Multikine® which commenced in
December 2010. As of December 31, 2010, CEL-SCI had cash, cash
equivalents and prepaid expenditures of $23 million.
Geert Kersten, Chief Executive Officer said, “Last quarter we
started our Phase III clinical trial for head and neck cancer in
the US. We are currently in the process of adding clinical sites in
another eight countries. This study, if successful, should make our
Multikine cancer drug part of the new standard of care treatment
for newly diagnosed head and neck cancer patients.”
CEL-SCI’s Phase III clinical trial is an open-label, randomized,
controlled, multi-center study designed to determine if Multikine
administered prior to current standard of care (Surgery plus
Radiotherapy or Surgery plus Concurrent Chemo radiotherapy) in
previously untreated subjects with Advanced Primary Squamous Cell
Carcinoma of the Oral Cavity/Soft Palate (Head and Neck cancer)
will result in an increased overall rate of survival versus the
subjects treated with standard of care only. CEL-SCI’s 880 patient
trial is expected to be the largest clinical study of head and neck
cancer ever conducted. It will also be the first trial in which
immunotherapy will be administered before any other traditional
means of care are attempted. This is significant because
conventional therapy weakens the immune system, and likely
compromises the benefits of immunotherapy.
About CEL-SCI Corporation
CEL-SCI Corporation is developing products that empower immune
defenses. Its lead product is Multikine. In Phase II clinical
trials Multikine was shown to be safe and well-tolerated, and to
improve the patients' overall survival by 33 percent at a median of
three and a half years following surgery.
CEL-SCI is also developing an immunotherapy (LEAPS-H1N1-DC) to
treat H1N1 hospitalized patients and a vaccine (CEL-2000) for
Rheumatoid Arthritis using its LEAPS technology platform. The
LEAPS-H1N1-DC treatment involves non-changing regions of H1N1
Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu as CEL-SCI
scientists are very concerned about the creation of a new more
virulent hybrid virus through the combination of H1N1 and Avian
Flu, or maybe Spanish Flu. The Company has operations in Vienna,
Virginia, and in/near Baltimore, Maryland.
For more information, please visit www.cel-sci.com.
CEL-SCI CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited) For the Three Months Ended December 31,
2010 2009 REVENUE: Rent income $ - $ 30,000 Grant and other
income 662,818 - Total revenue
662,818 30,000 EXPENSES:
Research and development, excluding
depreciation of $116,191 and $99,583 included below
3,264,428 2,805,127 Depreciation and amortization 141,147 119,581
General and administrative 1,573,277 1,358,141
Total expenses 4,978,852
4,282,849 LOSS FROM OPERATIONS (4,316,034 )
(4,252,849 ) (LOSS) GAIN ON DERIVATIVE INSTRUMENTS
(1,946,395 ) 23,340,267 INTEREST INCOME 52,879 110,219
INTEREST EXPENSE (41,402 ) (38,120 )
NET (LOSS) INCOME BEFORE INCOME TAXES (6,250,952 ) 19,159,517
INCOME TAX PROVISION - -
NET (LOSS) INCOME AVAILABLE TO COMMON SHAREHOLDERS $ (6,250,952 ) $
19,159,517 NET (LOSS) INCOME PER COMMON SHARE-BASIC $
(0.03 ) $ 0.10 NET (LOSS) INCOME PER COMMON
SHARE-DILUTED $ (0.03 ) $ 0.02 WEIGHTED AVERAGE
COMMON SHARES OUTSTANDING-BASIC 205,112,418
194,959,814 WEIGHTED AVERAGE COMMON SHARES
OUTSTANDING-DILUTED 205,112,418 256,198,162
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